CAPTAIN: Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome

Sponsor
University of Aarhus (Other)
Overall Status
Recruiting
CT.gov ID
NCT04850378
Collaborator
(none)
80
1
4
30.2
2.6

Study Details

Study Description

Brief Summary

The study aims to describe the biochemical coagulation profile and investigate the effect of Low molecular weight heparin and Apixaban on this profile in patients with nephrotic syndrome.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

The initial part of the study is a prospective cross-sectional study which will describe the biochemical coagulation profile in nephrotic patients. It will include 60 patients with nephrotic syndrome and data from 50 anonymous blood donors matched in age and gender for comparison.

The second part of the study is an open-label, controlled, non-randomized, interventional clinical trial consisting of 3 groups of patients with nephrotic syndrome or atrial fibrillation treated with either Dalteparin or Apixaban. The study participant is expected to be in stable condition after 4 full days of treatment. For administrative reasons, the final biochemical tests are performed on day 4, 5, 6 or 7 described as day 4 in this protocol.

  • Group A: Up to 50 patients with nephrotic syndrome treated with injection Dalteparin 200 Units/kg subcutaneous once a day for 4 days

  • Group B: 10 patients with nephrotic syndrome and membranous nephropathy treated with Apixaban 5 mg twice daily for 4 days.

  • Group C: 10 patients with atrial fibrillation and no kidney disease treated with Apixaban 5 mg twice daily for 4 days.

Patients participating in the initial part of the study will be included in det second part (Group A) if they meet the inclusion criteria. If the patient is diagnosed with membranous nephropathy it is possible to be included in the initial part as well as the second part (Group A and B).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
An open-label, controlled, non-randomized, interventional clinical trial.An open-label, controlled, non-randomized, interventional clinical trial.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Causes and Prevention of Thromboembolic Disease in Nephrotic Syndrome
Actual Study Start Date :
Mar 25, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Oct 1, 2023

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Coagulation profile in Nephrotic syndrome

Investigation of the biochemical coagulation profile in patients with nephrotic syndrome.

Experimental: Nephrotic syndrome

Nephrotic patients without diabetes.

Drug: Dalteparin
Drug: Dalteparin 200 units/kg once a day for 4-7 days.
Other Names:
  • Fragmin
  • Experimental: Membranous nephropathy and nephrotic syndrome

    Membranous nephropathy and nephrotic syndrome.

    Drug: Apixaban
    Drug: Apixaban 5 mg twice a day for 4-7 days.
    Other Names:
  • Eliquis
  • Active Comparator: Atrial fibrillation

    Atrial fibrillation with no kidney disease.

    Drug: Apixaban
    Drug: Apixaban 5 mg twice a day for 4-7 days.
    Other Names:
  • Eliquis
  • Outcome Measures

    Primary Outcome Measures

    1. Initial Thrombin Generation Assay in nephrotic patients treated with Dalteparin [Predose on Day 1]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy

    2. Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (Nadir TGA value) [Predose day 4]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy

    3. Steady state Thrombin Generation Assay (TGA) in nephrotic patients treated with Dalteparin (4 hours TGA value) [4 hours postdose on Day 4]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy

    4. Initial Thrombin Generation Assay in nephrotic patients treated with Apixaban [Predose on Day 1]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy.

    5. Thrombin Generation Assay in nephrotic patients treated with Apixaban over the first 24 hours. [24 hours]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy with blood samples at 2.5, 8, 24 hours.

    6. Steady state Thrombin Generation Assay in nephrotic patients treated with Apixaban. [Predose day 4]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy.

    7. Initial Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban [Predose on Day 1]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy.

    8. Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban over the first 24 hours. [24 hours]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy with blood samples at 2.5, 8, 24 hours.

    9. Steady state Thrombin Generation Assay in patients with atrial fibrillation and no kidney disease treated with Apixaban. [Predose day 4]

      Thrombin Generation Assay is used to monitor the anticoagulation therapy.

    10. Comparing Thrombin Generation Assay between group B and C. [Predose, 2.5, 8, 24 hours and predose Day 4]

      Comparing Thrombin Generation Assay in nephrotic patients treated with Apixaban and patients with atrial fibrillation treated with Apixaban.

    11. Comparing Thrombin Generation Assay between group A and C. [Baseline and predose Day 4]

      Comparing Thrombin Generation Assay in nephrotic patients treated with Dalteparin and patients with atrial fibrillation treated with Apixaban.

    12. Comparing Thrombin Generation Assay between group A and B. [Baseline and predose Day 4]

      Comparing Thrombin Generation Assay in nephrotic patients treated with Dalteparin and nephrotic patients treated with Apixaban.

    Secondary Outcome Measures

    1. Evaluation of bleeding-events durin the study. [Predose until 7 days after last dose of apixaban.]

      Number of cases with bleeding-events.

    2. Evaluation of thromboembolic complications during the study. [Predose until 7 days after last dose of apixaban.]

      Number of cases with thromboembolic complications

    3. Comparing plasma concentration of Apixaban between group B and C [Day 4]

      Comparing plasma-Apixaban in nephrotic patients and patients with atrial fibrillation.

    4. Comparing urine concentration of Apixaban between group B and C [Day 4]

      Comparing urine-Apixaban in nephrotic patients and patients with atrial fibrillation.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 79 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Nephrotic patients - no intervention

    • Age 18-79 years

    • Estimated Glomerular Filtration Rate (eGFR) > 49 mL/min/1.73 m2

    • P-albumin < 30 g/L

    • U-Albumin excretion > 2.2 g/day

    • Known glomerular disease including membranous nephropathy, which may cause nephrotic syndrome or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.

    Inclusion Criteria: Nephrotic patients treated with Dalteparin

    • Age 18-79 years

    • eGFR > 49 mL/min/1.73 m2

    • P-albumin < 25 g/L

    • U-Albumin excretion > 2.2 g/day

    • Known glomerular disease including membranous nephropathy, which may cause nephrotic syndrome or diagnostically unresolved nephrotic syndrome with a planed kidney biopsy.

    Inclusion Criteria: Nephrotic patients treated with Apixaban

    • Age 18-79 years

    • eGFR > 49 mL/min/1.73 m2

    • P-albumin < 25 g/L

    • U-Albumin excretion > 2.2 g/day

    • Membranous Nephropathy

    Inclusion Criteria: Patients with atrial fibrillation treated with Apixaban

    • Age 18-79 years

    • eGFR > 49 mL/min/1.73 m2

    • P-albumin > 36 g/L

    • U-Albumin excretion < 300 mg/day

    • Atrial Fibrillation

    Exclusion Criteria:
    • Contraindication to Apixaban

    • Contraindication to Dalteparin

    • Known allergy or intolerance to Apixaban

    • Known allergy or intolerance to Dalteparin

    • Treatment with anticoagulation for other reasons.

    • Treatment with cyclooxygenase-1-inhibitors or Adenosine Diphosphate (ADP) receptor inhibitors.

    • Known acquired or congenital coagulation defect non related to nephrotic syndrome or thromboembolic disease within 3 months.

    • Known diabetes mellitus.

    • Lack of compliance, comorbidity or other conditions that, in the patients unfit to participate in the trial.

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Aarhus University Hospital Aarhus Denmark 8200

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    • Principal Investigator: Sarah Kelddal, MD, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT04850378
    Other Study ID Numbers:
    • Prot-0824-2019
    First Posted:
    Apr 20, 2021
    Last Update Posted:
    May 23, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of Aarhus
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 23, 2022